Download Traditional pipeline: March 2016

Drug Pipeline Update
D Drug Insights > March 2016
→
New drug information
●● Briviact® (brivaracetam): UCB received Food and
Drug Administration (FDA) approval for their new
anticonvulsant. Briviact is approved as an adjunctive
therapy for the treatment of partial-onset seizures
in epilepsy patients over 16 years of age. It is similar
in mechanism of action to Keppra® (levetiracetam)
and generics.
→
Generic drug information
●● Oxistat® cream (oxiconazole cream, 1%): There is now a
generic version of Pharmaderm’s Oxistat cream for the
topical treatment of fungal infections.
●● Cyclogyl 0.5%® (cyclopentolate ophthalmic solution,
0.5%): Alcon’s Cyclogyl, used to produce mydriasis and
cycloplegia, is now available generically.
While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs
or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.
Drug Pipeline > March 2016
Page 2
New molecular entity approvals in the past twelve months
Generic name
Brand name
Manufacturer
Indication(s)
Date approved*
brivaracetam
Briviact
UCB
Seizure
February 2016
glycopyrronium
Seebri™ Neohaler
Novartis
COPD
November 2015
glycopyrronium/indacaterol
Utibron™ Neohaler
Novartis
COPD
November 2015
patiromer
Veltassa™
Relypsa
High potassium
October 2015
insulin degludec/insulin aspart
Ryzodeg™
Novo Nordisk
Diabetes
October 2015
insulin degludec
Tresiba™
Novo Nordisk
Diabetes
October 2015
cariprazine
Vraylar™
Allergan
Bipolar and schizophrenia
September 2015
rolapitant
Varubi™
Tesaro
Prevention and treatment of
chemotherapy induced nausea
and vomiting
September 2015
flibanserin
Addyi™
Sprout Pharmaceuticals
Hypoactive sexual desire disorder
(women)
August 2015
sacubitril/valsartan
Entresto™
Novartis
Heart failure
July 2015
brexpiprazole
Rexulti™
Otsuka/Lundbeck
Schizophrenia/depression
July 2015
eluxadoline
Viberzi™
Actavis
IBS-D
June 2015
ivabradine
Corlanor®
Amgen
Heart failure
April 2015
®
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
Drug Pipeline > March 2016
Page 3
Other new product approvals in the past twelve months
Generic name
Brand name
Manufacturer
Indication(s)
Date approved*
sumatriptan succinate injection
Zembrace
SymTouch™
Dr. Reddy’s
Migraine
February 2016
sumatriptan, intranasal powder
Onzetra™ Xsail™
Avanir and Optinose
Migraine
February 2016
lesinurad
Zurampic™
AstraZeneca
Gout
January 2016
amphetamine extended-release ODT Adzenys XR-ODT™ Neos Therapeutics
ADHD
January 2016
insulin human injection
Humulin® R
U-500 KwikPen
Lilly
Diabetes
January 2016
methylphenidate extended-release
QuilliChew ™ ER
Pfizer
ADHD
December 2015
insulin glargine
Basaglar™
Lilly
Diabetes
December 2015
naloxone
Narcan®
Adapt Pharma/
Lightlake Therapeutics
Opioid overdose
November 2015
calcipotriene/betamethasone,
aerosol foam
Enstilar®
Leo Pharma
Plaque psoriasis
November 2015
meloxicam
Vivlodex™
Iroko
Pain
October 2015
amphetamine
Dynavel™ XR
Tris Pharma
ADHD
October 2015
buprenorphine buccal film
Belbuca™
Endo, Biodelivery Sciences
Pain
October 2015
aripiprazole lauroxil
Aristada™
Alkermes
Schizophrenia
October 2015
morphine ER
MorphaBond™ ER
Inspirion Delivery
Diabetes
November 2014
aspirin, extended-release
Durlaza™
New Haven Pharmaceuticals
Cardiovascular prevention
September 2015
empagliflozin and metformin
Synjardy ™
Boehringer Ingelheim
Diabetes
August 2015
levetiracetam
Spritam™
Aprecia
Seizures
August 2015
tacrolimus
Envarsus ® XR
Veloxis Pharma
Prophylaxis of rejection in
kidney transplant
July 2015
doxycycline hyclate
Targadox™
Journey Medical Corporation
Treatment of various infections
June 2015
duloxetine 40 mg
Irenka™
Lupin Pharmaceuticals
Major depressive disorder,
generalized anxiety disorder,
diabetic peripheral neuropathic
pain, chronic musculoskeletal pain
June 2015
olodaterol/tiotropium
Stiolto™
Respimat®
Boehringer Ingelheim
COPD
May 2015
paliperidone palmitate
Invega Trinza™
Johnson & Johnson
Schizophrenia
May 2015
codeine/chlorpheniramine
Tuzistra™ XR
Tris Pharma/Vernalis
Cough and cold relief
May 2015
albuterol
Proair® RespiClick Teva
Asthma
April 2015
™
*Date indicates FDA approval date only. The product launch and marketing dates are determined by the approved product’s manufacturer.
Drug Pipeline > March 2016
Page 4
Pipeline watch
Generic name
Brand name
Manufacturer
Indication(s)
Anticipated FDA
decision date
gepirone ER
n/a
Fabre-Kramer
Pharmaceuticals
Depression
1Q2016
granisetron, extended-release
Sustol™
Heron Therapeutics
Nausea/vomiting
1st half 2016
safinamide
Xadago ™
Newron Pharmaceuticals
Parkinson’s disease
March 2016
calcifediol
Rayaldee
Opko Health
Chronic kidney disease and
vitamin D insufficiency
March 2016
glycopyrrolate/formoterol
n/a
AstraZeneca
COPD
2Q2016
aripiprazole, digital tablet
Abilify®
Otsuka/Proteus Health
Schizophrenia, bipolar disorder
and major depression
April 2016
dronabinol oral solution
n/a
Insys Therapeutics
Cachexia
April 2016
bromfenac 0.075%
BromSite ™
InSite Vision
Inflammation and pain associated
with cataract surgery
April 2016
methylnaltrexone
Relistor®
Valeant
Opioid-induced constipation
April 2016
pimavanserin
Nuplazid™
Acadia
Psychosis associated with
Parkinson's disease
April 2016
arbaclofen, extended-release
Ontinua™ ER
Osmotica
Spasticity associated with
multiple sclerosis
May 2016
sodium zirconium cyclosilicate
N/A
ZS Pharma
Treatment of hyperkalemia
May 2016
buprenorphine implant
Probuphine ™
Braeburn and Titan
Maintenance treatment of
opioid dependence
May 2016
epinephrine
N/A
Adamis Pharmaceuticals
Treatment of allergic reactions
(anaphylaxis)
June 2016
benzyhydrocodone/acetaminophen
N/A
KemPharm
Treatment of acute pain
(immediate release)
June 2016
lixisenatide/insulin glargine
LixiLan™
Sanofi
Diabetes
June 2016
testosterone
N/A
Lipocine
Replacement therapy
June 2016
Drug Pipeline > March 2016
Page 5
First generic approvals of top selling brand name drugs in the past twelve months
Generic name
Brand name
Brand manufacturer
Indication(s)
Date approved*
imatinib
Gleevec
Novartis
Cancer (multiple indications)
February 2016
dutasteride
Avodart®
GlaxoSmithKline
BPH
October 2015
memantine
Namenda®
Actavis
Alzheimer’s disease
July 2015
glatiramer
Glatopa™
Teva
Relapsing-remitting
multiple sclerosis
June 2015
aripiprazole
Abilify®
Bristol-Myers Squibb
Schizophrenia, bipolar disorder
and Tourette’s syndrome
May 2015
®
*Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within
three months of approval are listed and dated when they enter the market.
Drug Pipeline > March 2016
Page 6
Other first generic approvals in the past twelve months
Generic name
Brand name
Brand manufacturer
Indication(s)
Date approved*
oxiconazole cream, 1%
Oxistat cream
Pharmaderm
Fungal infection
March 2016
cyclopentolate ophthalmic solution, 0.5%
Cyclogyl 0.5%
Alcon
To produce mydriasis
and cycloplegia
March 2016
naftifine cream, 2%
Naftin®
Merz Pharmaceuticals
Fungal infection
February 2016
metformin modified release 24hr SR
Glumetza
Valeant
Diabetes
February 2016
norgestimate/ethinyl estradiol
Ortho Tri-Cyclen Lo
Jannsen
Oral contraceptive
January 2016
linezolid suspension
Zyvox
Pfizer
Treatment of bacterial
infection
December 2015
repaglinide/metformin
Prandimet™
NovoNordisk
Diabetes
December 2015
dutasteride/tamsulosin
Jalyn
GlaxoSmithKline
BPH
December 2015
trimipramine
Surmontil
Teva
Antidepressant
November 2015
nevirapine ER
Viramune ® XR
Boehringer Ingelheim
HIV
November 2015
paliperidone ER
Invega®
Janssen
Schizophrenia
October 2015
fluvastatin
Lescol XL
Novartis
High cholesterol
October 2015
testosterone transdermal gel, 1%
Androgel
AbbVie
Low testosterone
October 2015
pimozide
Orap
Teva
Tourette’s syndrome
October 2015
methyltestosterone
Testred and Android
Valeant
Hormone replacement
October 2015
memantine oral solution
Namenda
Actavis
Alzheimer’s disease
October 2015
rivastigmine TD patch
Exelon TD patch
Novartis
Alzheimer’s disease
September 2015
tretinoin gel, 0.05%
Atralin®
Valeant
Acne
September 2015
naproxen SR 24hr
Naprelan® SR
Almatica and
Shionogi Pharma
Pain
September 2015
tetrabenazine
Xenazine ®
Lundbeck
Chorea associated with
Huntington’s disease
August 2015
pramipexole extended-release
Mirapex®
Boehringer Ingelheim
Parkinson’s disease
August 2015
phenoxybenzamine
Dibenzyline®
Concordia
Pheochromocytoma
August2015
acetaminophen/caffeine/dihydrocodeine
Trezix®
Wraser Pharmaceuticals
Pain
August2015
megestrol acetate suspension
Megace ® ES
Par
For the treatment of
appetite loss
August2015
budesonide inhalation susp, 1 mg/2 mL
Pulmicort® Respules
AstraZeneca
Respiratory
August2015
almotriptan
Axert®
Jannsen
Migraine
July 2015
pyridostigmine bromide
Mestinon Timespan
Valeant
Myasthenia gravis
July 2015
bexarotene
Targretin
®
Valeant
Cutaneous t-cell lymphoma
July 2015
alosetron
Lotronex
®
Prometheus
IBS-D
June 2015
naftifine cream, 1%
Naftin
Merz
Fungal infections (topical)
June 2015
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risedronate
Actonel
Actavis
Osteoporosis
June 2015
norethindrone/ethinyl estradiol
Femhrt®
Actavis
Menopause symptoms
May 2015
tolcapone
Tasmar®
Valeant’
Parkinson’s disease
May 2015
benzonatate
Zonatuss ®
Vertical
Relief of cough
May 2015
metoclopramide ODT
Metozolv ODT
Salix
Relief of GERD
April 2015
norethindrone/ethinyl estradiol/FE
Generess FE
Warner Chilcott
Oral contraceptive
April 2015
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*Date usually indicates FDA approval date. The product’s launch date is determined by the manufacturer. Generic approvals that do not come to market within
three months of approval are listed and dated when they enter the market.
Drug Pipeline > March 2016
Page 7
Generics of top selling brand drugs potentially available soon
Generic name
Brand name
Brand manufacturer
Indication(s)
To market date*
rosuvastatin
Crestor
AstraZeneca
High cholesterol
May 2016
olmesartan and olmesartan/HCTZ
Benicar®/
Benicar® HCT
Daiichi-Sankyo
High blood pressure
October 2016
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03002301
*Expected launch dates are predictions made by Prime Therapeutics based on industry information.
2992-A1 © Prime Therapeutics LLC 03/16